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Open-Label Study of SPN-812 Administered With Psychostimulants in Children and Adolescents With ADHD

NCT04786990 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2024-05-01

Study results available
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Summary

This open label, flexible-dose study evaluating the safety and efficacy of SPN-812 administered with psychostimulants in children and adolescents (6 to 17 years of age) with Attention-Deficit/Hyperactivity Disorder (ADHD).

Conditions

  • Attention-Deficit/Hyperactivity Disorder (ADHD)

Interventions

DRUG

SPN-812

Viloxazine extended-release capsule

Sponsors & Collaborators

  • Supernus Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Jonathan Rubin, MD, MBA · Chief Medical Officer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-27
Primary Completion
2023-05-23
Completion
2023-07-26
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04786990 on ClinicalTrials.gov